What are the side effects and contraindications of Cabtreo (clindamycin phosphate, adapalene, benzoyl peroxide) gel and Winlevi (clascoterone) cream for the treatment of acne vulgaris in patients ≥12 years old?

Cabtreo and Winlevi for Acne: Side Effects and Contraindications

Cabtreo (Clindamycin 1.2%, Adapalene 0.15%, Benzoyl Peroxide 3.1%)

Cabtreo is FDA-approved for moderate to severe acne in patients ≥12 years old, applied once daily as a thin layer to affected areas, with demonstrated treatment success rates of approximately 50% at 12 weeks. 1

Side Effects

Common adverse effects include:

• Erythema (redness) 2
• Peeling and scaling 2
• Dryness 2
• Burning and stinging sensations 2
• Itching (pruritus) 2
• Skin discoloration 2

Serious but rare adverse effects:

• Severe colitis and pseudomembranous colitis (from clindamycin component) 2
• Anaphylaxis (hypersensitivity reactions) 2
• Photosensitivity reactions 2

The discontinuation rate due to adverse events with similar triple-combination formulations is low (≤1%). 3

Contraindications

Absolute contraindications include:

• History of hypersensitivity to clindamycin, benzoyl peroxide, adapalene, lincomycin, or any formulation component 2
• History of regional enteritis (Crohn's disease) 2
• History of ulcerative colitis 2
• History of antibiotic-associated colitis or pseudomembranous colitis 2

Drug Interactions and Precautions

Critical interactions to avoid:

• Should not be combined with erythromycin-containing products 2, 4
• Use caution with neuromuscular blocking agents (clindamycin enhances their effects) 2
• Avoid concomitant topical medications with strong drying effects (increases cumulative irritation) 2
• Minimize sun exposure, avoid tanning beds and sun lamps due to photosensitivity risk 2, 5

Special Populations

Pregnancy and nursing:

• Pregnancy Category C (combination products with benzoyl peroxide and retinoids) 2
• Unknown whether components are excreted in breast milk after topical application 2
• Use only if benefits outweigh risks 6

Pediatric use:

• Safety and effectiveness established for patients ≥12 years of age 2, 1
• Not established in children <12 years 2

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Winlevi (Clascoterone) Cream

Note: The provided evidence does not contain specific information about Winlevi (clascoterone) cream. Based on general medical knowledge, clascoterone is an androgen receptor inhibitor approved for topical treatment of acne in patients ≥12 years old, but detailed prescribing information, side effects, and contraindications are not available in the current evidence base provided.

What We Know from Available Evidence

The evidence focuses primarily on traditional acne therapies including clindamycin, benzoyl peroxide, adapalene, and tretinoin combinations. For accurate information about Winlevi's specific side effects and contraindications, refer to the FDA-approved prescribing information or drug label, which was not included in the provided evidence.

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Clinical Pearls for Cabtreo Use

Application technique:

• Apply once daily as a thin layer to the entire affected area 1
• Use after thoroughly washing, rinsing with warm water, and gently patting skin dry 2
• Avoid eyes, mouth, nasal creases, and mucous membranes 2

Common pitfalls to avoid:

• Do not use excessive amounts—a thin layer is sufficient 6
• Always counsel patients about sun protection and photosensitivity 2, 5
• Screen for gastrointestinal history before prescribing (colitis risk) 2, 4
• Warn about potential bleaching of fabrics from benzoyl peroxide component 2

Monitoring recommendations:

• Watch for signs of colitis (diarrhea, abdominal pain) 2
• Assess for excessive irritation, especially in first weeks of treatment 2
• Evaluate treatment response at 12 weeks 1